Drug Liability
From Learned Intermediary to Twitter
Restatement of Torts 402a
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(1) One who sells any product in a defective
condition unreasonably dangerous to the user or
consumer or to his property is subject to liability
for physical harm thereby caused to the ultimate
user or consumer, or to his property, if
 (a) the seller is engaged in the business of
selling such a product, and
 (b) it is expected to and does reach the user or
consumer without substantial change in the
condition in which it is sold.
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Limited Defenses under 402a
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(2) The rule stated in Subsection (1) applies
although
 (a) the seller has exercised all possible care in
the preparation and sale of his product, and
 (b) the user or consumer has not bought the
product from or entered into any contractual
relation with the seller.
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Comment I - Dangerous Products
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Products That Are Dangerous As Used
 Good Whiskey
 Good Tobacco
Are There Unexpected Risks?
 Fetal Alcohol Syndrome
 Premature Babies
Were There Misrepresentation?
 Tobacco Additives
 Claims that Smoking Is Not Addictive
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Comment K Unavoidably Unsafe Products
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Key Defense for Drugs
 Recognizes that Many Drugs are Very
Dangerous
 Old Pasteur Rabies Vaccine Example
Looks at the Label Information
 Does it Explain How to Use the Drug?
 Does it Warn about Dangers?
 Did it Get to the Decision-maker?
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Who Else is Liable?
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Usually Both Sellers and Manufacturers Are Liable
Health Care is Different
 Product v. Service Distinction
 The Patient is Not the Buyer
 The Doctor is Not the Seller
 The Hospital is Not (Considered) a Supplier
 Limited Liability for Pharmacies
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What is the Implications of Health Care
Providers not Being Liable?
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What is the incentive of a seller who can be liable
for product defects?
If you are a plaintiff's attorney, why do you go
after the drug manufacturer?
Why is the even more important in Louisiana?
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Product Must Be Defective
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Manufacturing Defect
 Easy to Prove
 Limited Number Affected
 Example: Improper Sterilization
Design Defect
 Effects Every Unit
 Thalidomide, DES, Mer-29
 Vioxx
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Prescription Drug Liability
History of the Medicine: Drug Law
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Step back in time, when the laws were formulated
Rx drugs were only advertised to physicians
Informed consent was not yet an accepted duty
Medical care was paternalistic
Rx drugs were not blockbusters and only a small
part of a small health care budget
Relatively few effective drugs
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Drug Labels and Comment K
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Modern drug law is products liability
The very nature of an Rx drug means that it
cannot be safely used by a consumer
Comment K tells us that you can only cure
dangerous drugs with warning
If the consumer cannot understand the warning
and criteria for the using the drug safely, who
can?
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The Label as Part of the Product
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If a drug cannot be safely used without a proper
label, then an inadequate label is a product defect
An effective drug label must have:
 Indications for use
 Information about effectiveness
 Contraindications for use
 Complications
 Interactions with other drugs
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How do We Judge the Adequacy of a
Label?
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Consumer products
 Reasonable consumer
 Foreseeable use
 Foreseeable misuse
Technical Products
 Skilled user
 We depend on limits in the distribution chain to keep
these products out of the hands of laypersons.
 Think blasting caps
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The Learned Intermediary
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Rx drug labels are written for physicians
Rx drugs can only be obtained with a prescription
The courts created the learned intermediary
doctrine
 The adequacy of the label is judged by a
reasonable physician standard
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Implications of the Learned Intermediary
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If the doc is given adequate information, but still used the
drug incorrectly, it is medical malpractice, but the
manufacturer is no liable.
There is no duty for the manufacturer to communicate
information to the patient, absent a PPI requirement
 It is the physician who decides whether the benefits of
the drug outweigh the risks, not the patient
Who is really the consumer of drugs in this classical
model?
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Attacking a Label
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The core attack on a label is that it does not include a
risk, so there can be no waiver of the risk
 DES - no warning of cervical cancer
 Vioxx - no warning of heart attack risk
A collateral attack is that the manufacturer lied to the FDA
about the benefits and that the drug should not have
been approved, and is thus too dangerous
 Psychiatric drugs for kids
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Who is a Learned Intermediary?
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Reyes v. Wyeth Laboratories, 498 F.2d 1264 (5th
Cir. 1974)
 Polio vaccinations
 Administered by a nurse
Individualized evaluation by a physician?
Is the nurse a learned intermediary?
Solved with standard form consents
 Why have consent for mandatory vaccinations?
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Dilution of Warnings - Over Promotion
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Stevens v. Parke, Davis & Co., 507 P.2d 653 (Cal.
1973)
 Chloromycetin (chloramphenicol)
 Valuable antibiotic
 Dangerous side effects, should only be used as
a last resort
 Widely promoted as a general use drug
Most common sin in the drug business
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Perez v. Wyeth Laboratories Inc., 161 N.J.
1, 734 A.2d 1245 (N.J. 1999)
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Norplant
Heavily promoted directly to women
Plaintiff sue, claiming the label was defective
because it denied them info
Is this a learned intermediary case?
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Direct to Consumer Marketing
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Why are contraceptives special?
How has the physician patient relationship
changed?
 First, with rare and wonderful exceptions, the
"`Norman Rockwell' image of the family doctor
no longer exists."
The court found a duty to the consumer when it
can be shown that the doctor cannot be counted
on to exercise judgment
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The Autism Cases and the Vaccine Injury
Compensation Fund
Stahl - Next time
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